JP2022541113A - Crimping device for artificial heart valve - Google Patents

Abstract

A crimping device includes a housing and a crimping band. The housing has a lumen for receiving the prosthetic valve. A crimping band is adjustably coupled to the housing and has a first end, a second end and a loop. A loop of the crimping band is disposed within the lumen and moves between the first and second configurations. In a first configuration, the loop has a first diameter and is configured such that a prosthetic valve in a radially expanded configuration can be radially positioned within the loop. In a second configuration, the loop has a second diameter and is configured to exert a radial force on the prosthetic valve to move the heart valve to a radially compressed configuration. The loops of the crimping band are configured to contact less than half the axial length of the prosthesis.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of US Application No. 62/876,206, filed July 19, 2019, which is incorporated herein by reference.

TECHNICAL FIELD The present disclosure relates generally to heart valve prostheses, and more particularly to crimping devices for heart valve prostheses.

The human heart can suffer from various valvular diseases. These valvular diseases can result in significant heart failure, ultimately requiring repair of the native valve or replacement of the native valve with a prosthetic valve. There are several known repair devices (eg, stents) and prosthetic valves and several known methods of implanting these devices and valves in humans. Percutaneous, minimally invasive surgical approaches are used in a variety of procedures to deliver prosthetic medical devices to locations within the body that are not readily accessible by surgery or where non-surgical access is desirable. In one specific example, a prosthetic heart valve is attached to the distal end of the delivery device in a crimped state and passed through the patient's vasculature (e.g., through the femoral artery and aorta) until the prosthetic heart valve reaches the implantation site within the heart. ) can be advanced. The prosthetic heart valve is then expanded to its functional size. There are various types of expandable heart valve prostheses, including balloon-expandable, self-expandable, and mechanically expandable.

A mechanically expandable heart valve prosthesis can include a frame with a plurality of struts pivotally connected together. Pivotally connected struts of the frame are movable between radially expanded and radially compressed configurations by actuating mechanical actuators coupled to the frame. .

U.S. Pat. No. 10,603,165 U.S. Patent Application Publication No. 2018/0311039 U.S. Patent Application Publication No. 2018/0344456 U.S. Patent Application Publication No. 2019/0060057 WO 2020/081893 pamphlet

Due to the unique configuration of mechanically expandable heart valve prostheses, there is a need for devices and methods specifically configured for mechanically expandable heart valve prostheses.

Disclosed herein are devices and methods specifically configured for mechanically expandable prosthetic devices, including prosthetic heart valves and stents. In particular, the present disclosure describes various devices and methods configured for crimping mechanically expandable prostheses. The disclosed crimping apparatus and methods can provide advantages over previous crimping apparatus and methods, as further described below.

In one representative embodiment, a crimping device includes a housing and a crimping band. The housing has a lumen configured to receive a prosthetic heart valve. A crimping band is adjustably coupled to the housing and includes a first end, a second end and a loop. A loop of the crimping band is disposed within the lumen of the housing and is movable between a first configuration and a second configuration. In a first configuration, the loop of the crimping band has a first diameter and is configured such that a prosthetic heart valve in a radially expanded configuration can be radially positioned within the loop. In the second configuration, the loops of the crimping band have a second diameter and exert a radial force on the prosthetic heart valve to radially compress the prosthetic heart valve from the radially expanded configuration. Configured to move to configuration. The loops of the crimping band are configured to contact less than half the axial length of the prosthetic heart valve.

In some embodiments, the loops of the crimping band are configured to contact less than one quarter of the axial length of the prosthetic heart valve.

In some embodiments, the loops of the crimping band are configured to contact less than one-eighth of the axial length of the prosthetic heart valve.

In some embodiments, the first end of the crimping band is fixed relative to the housing and the second end of the crimping band connects the loops of the crimping band to the first configuration and the second configuration. is moveable relative to the housing to move between the

In some embodiments, the first and second ends of the crimping band are movable relative to the housing to move the loops of the crimping band between the first configuration and the second configuration. is.

In some embodiments, the housing includes a band opening extending from the housing lumen to the housing outer surface, the band opening configured to allow the crimping band to extend therethrough. there is

In some embodiments, the band opening in the housing includes an actuation portion and a locking portion. When the crimping band is radially aligned with the actuation portion of the band opening, the crimping band is movable relative to the housing so that the crimping band is radially aligned with the locking portion of the band opening. When closed, the housing limits relative movement between the crimping band and the housing.

In some embodiments, the crimping device further includes a locking mechanism coupled to the housing and configured to limit relative movement between the crimping band and the housing.

In some embodiments, the locking mechanism is positioned adjacent the band opening of the housing.

In some embodiments, the locking mechanism includes a plurality of jaws, the jaws being movable between an open configuration spaced from the crimping band and a closed configuration contacting the crimping band.

In some embodiments, the jaws include mating features configured to hold the jaws in the closed configuration.

In some embodiments, the mating features of the jaws include interlocking tabs extending from the jaws.

In some embodiments, the crimping band includes an indicator configured to indicate to the user that the heart valve prosthesis is fully radially compressed.

In some embodiments, the crimping apparatus further includes one or more stop elements extending outwardly from the crimping band, the stop elements to limit relative movement between the crimping band and the housing. is configured to

In some embodiments, the crimping band has only one loop.

In another exemplary embodiment, a crimping device for a mechanically expandable heart valve prosthesis includes a housing and a crimping band. The housing includes a base and a body. A body extends from the base and includes a lumen configured to receive a mechanically expandable heart valve prosthesis. The body further includes a first opening and a second opening. The first and second openings are spaced apart and extend from an inner surface of the body defining the lumen to an outer surface of the body. The crimping band includes a first end, a second end, and only one loop disposed between the first and second ends. A loop of the crimping band includes a width less than the axial length of the mechanically expandable heart valve prosthesis.

In some embodiments, the crimping band is a flexible polymeric band.

In some embodiments, the crimping band is a flexible suture.

In some embodiments, the crimping band is a flexible wire.

In another exemplary embodiment, a method of crimping an implantable device is provided. The method includes placing the implantable device within a loop of the crimping band with the implantable device radially expanded. The method further includes pulling the crimping band such that the loop decreases in diameter and contacts the first portion of the implantable device and moves the implantable device to a radially compressed configuration. The crimping band is configured to exert a radial compressive force on the implantable device when the crimping band is pulled. The first portion of the implantable device includes less than half the axial length of the implantable device.

In some embodiments, the method further comprises advancing the capsule of the delivery device over the second portion of the implantable device while the crimping band is tensioned. The second portion includes less than half the axial length of the implantable device.

In some embodiments, the method further comprises loosening the crimping band and advancing the capsule of the delivery device over the first portion of the implantable device and the third portion of the implantable device. Together, the first portion, the second portion, and the third portion of the implantable device comprise the axial length of the implantable device.

Various innovations of this disclosure can be used in combination or separately. This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. . The foregoing and other objects, features and advantages of the present disclosure will become more apparent from the following detailed description, claims and accompanying drawings.

1 is a perspective view of an exemplary crimping device; FIG. 2 is a perspective view of a crimping band of the crimping device of FIG. 1; FIG. Figure 2 is a detailed view of the locking mechanism of the crimping device of Figure 1, showing the locking mechanism in an unlocked configuration; Figure 2 is a detailed view of the locking mechanism of the crimping device of Figure 1, showing the locking mechanism in a locking configuration; 2 is a perspective view of the crimping device of FIG. 1 and an exemplary delivery assembly, the delivery assembly including a prosthetic heart valve and a delivery device; FIG. 6 is a perspective view of the crimping device of FIG. 1 and the delivery assembly of FIG. 5 showing a prosthetic heart valve radially disposed within the crimping device in a radially expanded configuration; FIG. 6 is a perspective view of the crimping device of FIG. 1 and the delivery assembly of FIG. 5 showing the prosthetic heart valve radially disposed within the crimping device and in a radially compressed configuration; FIG. 6 is a perspective view of the force control mechanism, the crimping device of FIG. 1, and the delivery assembly of FIG. 5, showing the force control mechanism coupled to the crimping device; FIG. 6 is a perspective view of the crimping device of FIG. 1 and the delivery assembly of FIG. 5 showing a prosthetic heart valve held in a radially compressed configuration by a locking mechanism of the crimping device; FIG. 6 is a perspective view of the crimping device of FIG. 1 and the delivery assembly of FIG. 5 showing a prosthetic heart valve held in a radially compressed configuration by a locking mechanism of the crimping device and a capsule of the delivery device; FIG. 6 is a perspective view of the crimping device of FIG. 1 and the delivery assembly of FIG. 5 showing a prosthetic heart valve held in a radially compressed configuration by a capsule of the delivery device and released from the crimping device; FIG. 6 is a perspective view of the crimping device of FIG. 1 and the delivery assembly of FIG. 5 showing a prosthetic heart valve fully loaded into the capsule of the delivery device; FIG. FIG. 12 is a perspective view of another exemplary crimping device showing the crimping band in a relaxed state; Figure 14 is a perspective view of the crimping device of Figure 13, showing the crimping band in a tensioned state; 14 is a detailed side view of the housing of the crimping device of FIG. 13; FIG. 14 is a detailed perspective view of the crimping device of FIG. 13 showing the crimping band in an unlocked configuration; FIG. 14 is a detailed perspective view of the crimping device of FIG. 13, showing the crimping band in a locking configuration; FIG.

Overall considerations

For purposes of this description, certain aspects, advantages and novel features of embodiments of the disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations with each other. These methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, and there is no question that any one or more specific advantages of the disclosed embodiments may exist. Nor is it required to be resolved.

Although some operations of the disclosed embodiments are described in a particular, sequential order for convenience of presentation, the manner in which this description is presented imposes a particular order on the specific language set forth below. It should be understood to include rearrangement unless required. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Also, for the sake of simplicity, the accompanying figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation, but are readily identifiable by those skilled in the art.

As used in this application and in the claims, the singular forms "a," "an," and "the" include plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Further, the term "coupled" generally means physically, mechanically, chemically, magnetically, and/or electrically coupled or coupled, unless specific language to the contrary , does not exclude the presence of intermediate elements between conjoined or related items.

As used herein, the term "proximal" refers to a location, direction, or portion of the device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to a location, direction, or portion of the device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., out of the patient's body). For example, movement of the device (into the patient's body). The terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions, unless explicitly defined otherwise.

exemplary embodiment

Although disclosed herein are devices and methods specifically configured for mechanically expandable prosthetic heart valves, the disclosed devices and methods may in some cases be used with other types of prostheses. It can be used in heart valves (eg, balloon-expanding and/or self-expanding heart valve prostheses) or other prostheses (eg, stents). In particular, the present disclosure describes various devices and methods configured for radially compressing (“crimping”) mechanically expandable prosthetic heart valves.

The disclosed devices and methods improve the crimping behavior of some valves, such as mechanically expandable prosthetic heart valves, which can uniformly collapse/crimp as a result of localized crimping forces applied to the prosthetic heart valve. is configured to leverage and/or utilize In other words, the devices and methods disclosed herein may be particularly advantageous for crimping prosthetic heart valves where collapse of a portion of the valve results in collapse of the entire prosthetic heart valve.

Accordingly, the disclosed crimping devices and methods can provide advantages over previous crimping devices and methods, particularly when used in mechanically expandable prosthetic heart valves. For example, the disclosed crimping device is quick and easy to use. The disclosed crimping device is also simpler, safer, and cheaper to manufacture than typical crimping devices because there are relatively few moving parts/mechanisms. Additional features and advantages are described below.

FIG. 1 shows a crimping device 100 according to one embodiment. The crimping device 100 can include two main components: a housing 102 and a crimping band 104. As shown in FIG. In some embodiments, crimping device 100 can also include locking mechanism 106 . Housing 102 can be configured to support crimping band 104 and/or locking mechanism 106 . The crimping band 104 can form a loop 108 and can be moved relative to the housing 102 and locking mechanism 106 to adjust the size of the loop 108 in a lasso-like manner. A locking mechanism 106 can selectively secure the crimping band 104 to the housing 102, thereby securing the loop 108 in a desired configuration. Accordingly, the crimping apparatus 100 may be used to radially compress a mechanically expandable prosthetic heart valve from a radially expanded configuration (eg, a functional configuration), for example, as shown in FIGS. It can be radially compressed or crimped into a configuration (eg, a delivery configuration). Additional details regarding the crimping device 100 and methods of using the crimping device 100 to crimp a prosthetic heart valve are provided below.

Referring again to FIG. 1, the housing 102 of the crimping device 100 can include a base 110 and a body 112. As shown in FIG. Base 110 of housing 102 can be configured to support and/or stabilize crimping apparatus 100 . A body 112 extends from the base 110 and can be configured to support the crimping band 104 and to receive a prosthetic heart valve.

Base 110 of housing 102 may be configured to engage a table or bench in some cases. In some embodiments, base 110 can include one or more attachment features configured to allow housing 102 to be attached to a table. For example, the mounting features can include openings, slots, etc. configured to receive fasteners (eg, bolts, screws, etc.) that can couple the housing 102 to a table. In some embodiments, one or more surfaces of base 110 include friction elements ( for example, polymer pads and/or coatings).

Body 112 of housing 102 can include lumen 114 configured to receive a prosthetic heart valve and/or delivery device (see, eg, FIG. 6). Body 112 can also include one or more apertures configured to receive crimping band 104 . For example, in the illustrated embodiment, body 112 includes first opening 116 and second opening 118 . First and second openings 116 , 118 can extend from an outer surface 120 of body 112 to an inner surface 122 of body 112 that defines lumen 114 .

First and second openings 116 , 118 in body 112 can be circumferentially spaced from one another around lumen 114 . For example, in some embodiments, the first and second openings 116, 118 are directly across from each other (eg, 180 degrees apart) with respect to the body 112. In other embodiments, the first and second openings 116, 118 can be circumferentially spaced about 90-180 degrees from each other. In some embodiments, the first and second openings 116, 118 can be circumferentially spaced about 135-180 degrees from each other.

Although not shown, in some embodiments, body 112 can also include grooves or depressions formed in interior surface 122 . The grooves at least partially receive the loops 108 of the crimping band 104 to selectively hold the loops of the crimping band 104 against the inner surface 122 of the body 112 (e.g., to position a prosthetic heart valve within the lumen 114). when you do).

In the illustrated embodiment, outer surface 120 of body 112 includes a generally U-shape such that body 112 includes a generally annular shape. In other embodiments, the outer surface 120 of the body 112 can include various other shapes (eg, rectangular, triangular, etc.).

Housing 102 can be formed from a variety of materials such as polymers, metals, composites, and the like.

Referring to FIG. 2, crimping band 104 of crimping apparatus 100 can include first end 124 and second end 126 . As noted above, the crimping band 104 can be arranged to form a loop 108 between the first and second ends 124,126. In some cases, crimping band 104 has only one loop. In other cases, the crimping band 104 can include multiple loops (eg, 2-5). In some embodiments, loop 108 can be formed by spiraling crimping band 104 . In other embodiments, the loop 108 can be formed by tying a knot (eg, a stop knot) on the crimping band 104 .

Referring to FIG. 1, crimping band 104 has first end 124 of crimping band 104 extending through first opening 116 of housing 102 and loop 108 of crimping band 104 extending through housing 102 . Disposed within lumen 114 , crimping band 104 can be coupled to housing 102 such that second end 126 extends through second opening 118 of housing 102 . The diameter of loop 108 can be adjusted by pulling or loosening crimping band 104 .

The crimping band 104 and the first and second openings 116, 118 of the housing 102 are configured such that the crimping band 104 can move relative to the first and second openings 116, 118 of the housing 102. be able to. Accordingly, the diameter of loop 108 of crimping band 104 can be adjusted by pulling or loosening crimping band 104 . In some embodiments, both the first and second ends 124, 126 of the crimping band 104 are movable relative to the housing 102. In such embodiments, the crimping band 104 can be tensioned by moving both the first and second ends 124, 126 away from each other (eg, by pulling the ends). can. In other embodiments, as shown in the illustrated embodiment, one end (e.g., first end 124) of crimping band 104 can remain fixed relative to housing 102, allowing the crimp to The other end (eg, second end 126 ) of ping band 104 can be moved relative to housing 102 . In such embodiments, the crimping band 104 can be tensioned by moving the free end of the crimping band away from the fixed end of the crimping band 104 .

The tension of the crimping band 104 can be adjusted manually and/or automatically. For example, in some embodiments, the crimping band 104 can be pulled and/or loosened by manually pulling/loosening the crimping band 104 by hand. In other embodiments, the crimping band 104 can be adjusted automatically, such as by coupling the crimping band 104 (and/or spool) to an electric motor. In such embodiments, the crimping apparatus 100 can further include one or more actuators (eg, buttons, switches, etc.) configured to actuate the electric motor.

In some embodiments, one end of crimping band 104 can be fixed to housing 102 . For example, one end of crimping band 104 can be secured to housing 102 with adhesive and/or fasteners. As another example, one end of crimping band 104 can be integrally formed (eg, co-molded) with housing 102 . As yet another example, the crimping band 104 can have a stop element disposed thereon and/or coupled thereto and configured to limit movement between the crimping band 104 and the housing 102 . . In the illustrated embodiment, the crimping band 104 has a stop element 128 located at the first end 124 of the crimping band 104 . When the crimping band 104 is tensioned (eg, when the second end 126 of the crimping band 104 is pulled away from the housing 102), the first end 124 of the crimping band 104 is pulled toward the first end. The stopper element 128 can be larger than the first opening 116 in the housing 102 so that the opening 116 cannot be "pulled through."

In the illustrated embodiment, the stop element 128 includes a flange integrally formed with and extending radially outwardly from the main portion of the crimping band 104 . In other embodiments, the stop element can be a knot formed in the crimping band 104. FIG. In still other embodiments, the stop elements can be ferrules, caps, and/or other members coupled (eg, clamped) to the ends of the crimping band 104 .

The crimping band 104 can be a flexible element such as a band, cord, wire, suture, or the like. Crimp band 104 can be formed from a variety of materials. For example, the crimping band 104 may be made of polymers (eg, nylon, polyethylene (PE), ultra-high molecular weight polyethylene (UHMWPE) (eg, Dyneema® fiber), etc.) and/or metals (eg, stainless steel, nitinol, titanium, etc.).

In the illustrated embodiment, the crimping band 104 has a generally circular cross-sectional profile in a plane perpendicular to the longitudinal axis of the crimping band 104 . In other embodiments, the crimping band 104 can have various other cross-sectional profiles (eg, rectangular, oval, etc.).

Referring to FIG. 1, locking mechanism 106 of crimping device 100 can be coupled to housing 102 . 3-4, locking mechanism 106 moves between an unlocked configuration (FIG. 3) and a locked configuration (FIG. 4) to lock crimping band 104 and locking mechanism 106 (and housing 102) together. can be selectively limited to relative movement between Accordingly, the locking mechanism 106 can be used to selectively retain the crimping band 104 in a desired configuration (eg, a particular diameter and/or a tensioned/relaxed state).

Locking mechanism 106 may include a pair of jaws 130 . Jaws 130 of locking mechanism 106 are pivotally coupled together such that jaws 130 can move between an open state (eg, FIG. 3) and a closed state (eg, FIG. 4). be able to. In the open state, jaws 130 of locking mechanism 106 are spaced apart from crimping band 104 so that crimping band 104 can move relative to jaws 130 and housing 102 . Thus, with jaws 130 open, second end 126 of crimping band 104 can move relative to locking mechanism 106 and housing 102 to adjust the diameter of loop 108 of crimping band 104. . In the closed state, the jaws 130 of the locking mechanism 106 engage the second end 126 of the crimping band 104, thereby fixing the diameter of the loops 108 of the crimping band 104. 104 , locking mechanism 106 and housing 102 to limit relative movement.

In some embodiments, jaws 130 of locking mechanism 106 can have mating features 132 . The mating features 132 can be configured to engage one another so as to releasably secure the jaws closed, as shown in FIG. For example, mating features 132 of jaws 130 can include tabs configured to overlap and engage one another (eg, similar to locking features of a hemostat).

In some embodiments, one or more of jaws 130 of locking mechanism 106 can include a recess configured to receive a portion of crimping band 104 . The dimples can be configured to improve the frictional engagement between the jaws 130 and the crimping band 104 by increasing the surface area of the jaws that contacts the crimping band 104 . In some embodiments, the indentation can include a semi-circular cross-sectional profile in a plane perpendicular to the longitudinal axis of the crimping band 104 .

Instead of or in addition to dimples, jaws 130 of locking mechanism 106 can include one or more friction-enhancing elements or coatings. For example, the jaws 130 can include protrusions (eg, ribs) and/or textures (eg, non-smooth) configured to increase frictional engagement between the jaws 130 and the crimping band 104. can. Additionally or alternatively, jaws 130 can include a coating that increases the frictional engagement between jaws 130 and crimping band 104 .

In the illustrated embodiment, the crimping device 100 includes only one locking mechanism 106, which is positioned adjacent the second opening 118 of the housing 102 and engages the second end 126 of the crimping band 104. is configured to In other embodiments, locking mechanism 106 can be positioned adjacent first opening 116 . In still other embodiments, the crimping device 100 can include more than one (eg, two) locking mechanisms. For example, the crimping device can include a locking mechanism positioned adjacent each opening in the housing and configured to engage a respective end of the crimping band.

The crimping device 100 can be used, for example, to crimp a prosthetic heart valve from a radially expanded configuration to a radially compressed configuration. The prosthetic heart valve can be releasably coupled to a delivery device configured for implanting the prosthetic heart valve. For example, FIGS. 5-12 show the crimping device 100 in use with a delivery assembly 200 including a prosthetic heart valve 202 and a delivery device 204. FIG. Crimping device 100 is used to radially compress prosthetic heart valve 202 and hold prosthetic heart valve 202 in a radially compressed state while prosthetic heart valve 202 is loaded into capsule 206 of delivery device 204 . be able to. Additional details of exemplary crimping procedures and delivery assembly 200 are provided below.

Referring to FIG. 5, the prosthetic heart valve 202 of the delivery assembly 200 can include a frame 208 and a valve structure (not shown for purposes of illustration). The frame 208 of the heart valve prosthesis 202 can have multiple struts pivotally coupled together. Accordingly, the frame 208 of the heart valve prosthesis 202 is in a radially expanded and axially shortened configuration (e.g., FIG. 5) by applying a force (e.g., radially and/or axially) to the heart valve prosthesis 202. ) and a radially compressed, axially elongated configuration (eg, FIG. 7). Prosthetic heart valve 202 can be referred to as a mechanically expandable prosthetic heart valve.

Required to radially compress the heart valve prosthesis 202 (and/or other mechanically expandable heart valve prostheses) because the struts of the frame of the heart valve prosthesis 202 can pivot with respect to each other The force is relatively less than that required to radially compress typical self-expanding and balloon-expanding heart valve prostheses.

Although not shown, prosthetic heart valve 202 can include one or more mechanical actuators configured to apply force to frame 208 and/or lock frame 208 in a desired configuration. . Additional details regarding exemplary mechanically expandable prosthetic valves can be found, for example, in US Pat. incorporated herein by

Still referring to FIG. 5, the delivery device 204 of the delivery assembly 200 includes a first shaft 210 (which may also be referred to as the "outer shaft 210"), a second shaft 212 (which may also be referred to as the "inner shaft 212"). ), and a nosecone 214 . Outer shaft 210 is disposed at the distal end of outer shaft 210 and includes a capsule 206 (also referred to as a "sheath") configured to receive and retain a prosthetic heart valve therein in radial compression. can). Inner shaft 212 may extend through outer shaft 210 . Nosecone 214 may be coupled to the distal end of inner shaft 212 . Inner and outer shafts 210, 212 are movable relative to each other. Although not shown, delivery device 204 is coupled to one or more additional shafts and/or shafts 210, 212 configured to releasably couple prosthetic heart valve 202 to delivery device 204. One or more other components may be included, including one or more handles. Further details regarding delivery devices and coupling prosthetic heart valves to delivery devices can be found, for example, in US Pat.

To prepare the delivery device 204 to receive the prosthetic heart valve 202, the inner shaft 212 of the delivery device 204 is positioned with the nosecone 214 distal to the distal end of the capsule 206, as shown in FIG. can be positioned relative to the outer shaft 210 such that Prosthetic heart valve 202 can be positioned over nosecone 214 and inner shaft 212 such that prosthetic heart valve 202 is axially positioned between nosecone 214 and the distal end of capsule 206 .

Although not shown, a prosthetic heart valve can be releasably coupled to the delivery device. This can be accomplished, for example, by releasably coupling the actuation shaft of the delivery device to one or more actuators of the heart valve prosthesis.

6, delivery assembly 200 includes nosecone 214 and distal ends of inner shaft 212 extending through lumen 114 (FIG. 5) of crimping device 100 and prosthetic heart valve 202 extending through crimping device 100. It is positioned relative to crimping device 100 such that it is positioned within lumen 114 .

As shown in FIG. 6, the crimping device 100 can be configured so that the crimping band 104 axially overlaps and contacts only a portion of the axial length of the prosthetic heart valve 202 . As used herein, the axial length of a prosthetic heart valve is the length of the prosthetic heart as measured from the inflow end of the frame to the outflow end of the frame when the frame is in its fully expanded, functional configuration. is the length of the valve frame. In some embodiments, the crimping band 104 can axially overlap and contact less than half the axial length of the prosthetic heart valve 202 . In some embodiments, the crimping band 104 can axially overlap and contact less than one quarter of the axial length of the prosthetic heart valve 202 . In certain embodiments, the crimping band 104 can axially overlap and contact less than one eighth of the axial length of the prosthetic heart valve 202 . This is in marked contrast to typical crimping devices, which have crimping elements (eg, jaws) configured to axially overlap and contact the entire (or at least most) length of the prosthetic heart valve. The crimping device 100 is configured to utilize the low crimping forces required to compress the mechanically expandable heart valve prosthesis 202, thus compressing the prosthesis by contacting only a relatively small portion of the prosthesis. Because the entire heart valve can be compressed, crimping band 104 of crimping device 100 can be relatively narrow.

As shown in FIG. 7, with the prosthetic heart valve 202 positioned within the crimping apparatus 100, the prosthetic heart valve 202 can be radially compressed by pulling on the crimping band 104. As shown in FIG. This can be accomplished by pulling second end 126 of crimping band 104 away from housing 102 . As a result, the loops 108 of the crimping band 104 contract radially, exerting a radial compressive force on a portion of the frame 208 of the heart valve prosthesis 202, causing the struts of the frame 208 to pivot relative to each other, This radially compresses the entire frame 208 due to the pivotal connections between the struts of the frame 208 .

Also, due to the pivoting struts of the heart valve prosthesis 202, the amount of force required to compress the heart valve prosthesis 202 is relatively low. Accordingly, the user radially displaces prosthetic heart valve 202 by simply grasping second end 126 of crimping band 104 and pulling crimping band 104 away from housing 102 (eg, in the direction of arrow 134). can provide the force necessary to compress the Thus, the crimping device 100 is compared to typical crimping devices, which may require complex mechanics and/or require the user to apply large forces to radially compress the prosthetic heart valve. As such, it can be relatively simple and easy to use.

In some embodiments, the crimping device 100 can include one or more indicators configured to provide a user with information about the crimping of the heart valve prosthesis or its status. The indicator can be configured, for example, to indicate to the user that the prosthetic heart valve is fully radially compressed. As shown in FIG. 7, crimping band 104 includes indicator 136 . Indicators 136 may be markings, colors, symbols, and/or any other type of visual indication.

When loop 108 of crimping band 104 (and thus the heart valve prosthesis) is in a radially expanded configuration (eg, FIG. 6), indicator 136 is positioned within housing 102 (eg, adjacent inner surface 122 of housing 102). ), and when the loop 108 of the crimping band 104 (and thus the heart valve prosthesis) is in a predetermined radially compressed configuration (e.g., FIG. 7), the indicator 136 is positioned outside the housing 102. An indicator 136 can be positioned relative to the crimping band 104 such that it is positioned at (eg, adjacent to the locking mechanism 106). As such, the indicator 136 can notify the user that the prosthetic heart valve is fully crimped, which can help prevent the prosthetic heart valve from being over-crimped. .

Additionally or alternatively, the crimping device 100 can include a stop element (not shown) coupled to the crimping band. The stop element is configured to allow relative movement between the crimping band 104 and the housing 102 up to a predetermined point and to limit relative movement between the crimping band 104 and the housing 102 beyond the predetermined point. be able to. The stop element can be radially larger than the second opening 118 of the housing 102 . Accordingly, the stop element can be disposed within lumen 114 of housing 102 when loop 108 of crimping band 104 is in a radially expanded configuration (eg, FIG. 6). As the crimping band 104 is pulled to contract the loop 108 , the stopper element can move toward the second opening 118 of the housing 102 . When the crimping band 104 reaches a predetermined point, the stop element contacts the inner surface 122 of the housing 102 adjacent the second opening 118, thereby inhibiting further movement of the crimping band 104 relative to the housing 102. can be prevented. In some embodiments, the stop element can be a knot or other radial projection that is an integral part of the crimping band. In other embodiments, the stop elements can be separate elements (eg, ferrules or cable stops) coupled to the crimping band 104 .

Alternatively or in addition to indicator 136 and/or stop elements, crimping apparatus 100 may further include a force control mechanism. The force control mechanism can be configured to limit and/or indicate the force applied to crimping band 104 . For example, as shown in FIG. 8, the crimping apparatus 100 can include a spring load cell 138 (which can also be referred to as a "spring scale") coupled to the second end 126 of the crimping band 104. . A spring load meter 138 can provide a reading of the amount of force applied to the crimping band 104 (eg, in pounds and/or Newtons). In another embodiment, the force control mechanism is in the form of a crimping band made of an elastic material configured to elongate (i.e. elastically deform) when the force applied to the crimping band reaches a certain amount. can take In such an embodiment, the user can pull on the crimping band 104 until it begins to stretch, at which point the user knows that the prosthetic heart valve has been fully crimped and thus is crimped. Pulling on the ping band 104 will stop.

In embodiments that include an electric motor configured to adjust the tension of the crimping band 104, the crimping device 100 is configured to limit the force that the crimping band can apply to the prosthetic heart valve. Any of the above force (eg, torque) limiting mechanisms may be included. For example, the crimping apparatus 100 can include a slip clutch and/or electronic circuitry configured to limit current flow to the motor.

Once the heart valve prosthesis is crimped into the desired radially compressed configuration, a locking mechanism can be used to hold the prosthesis 202 in the crimped configuration. Locking mechanism 106 may be activated by moving jaws 130 of locking mechanism 106 into contact with crimping band 104, as shown in FIG. Jaws 130 can thus limit relative movement between crimping band 104 and housing 102 . This holds the loops 108 of the crimping band 104 in contact with the prosthetic heart valve 202, thereby holding the prosthetic heart valve 202 in a radially compressed configuration.

When in the radially compressed configuration, prosthetic heart valve 202 can be loaded into capsule 206 of delivery device 204 . This axially extends the outer shaft 210 of the delivery device 204 relative to the prosthetic heart valve 202 such that the capsule 206 extends radially across the proximal end of the prosthetic heart valve 202, as shown in FIG. This can be achieved by moving Outer shaft 210 can move axially relative to prosthetic heart valve 202 until the distal end of capsule 206 is positioned adjacent crimping band 104 .

Even though the capsule 206 is only placed over a portion of the heart valve prosthesis 202 , the capsule 206 of the delivery device 204 is used to radially move the heart valve prosthesis 202 while the prosthesis 202 is released from the crimping device 100 . can be held in a compressed configuration. To release the prosthetic heart valve 202, the locking mechanism 106 can be unlocked by opening the jaws 130 and the crimping band 104 is radially spaced from the prosthetic heart valve 202, as shown in FIG. can be radially expanded to

As shown in FIG. 12, the capsule 206 of the delivery device 204 can then be moved axially relative to the heart valve prosthesis 202 such that the capsule 206 extends over the heart valve prosthesis 202 . Shafts 210 , 212 can be moved relative to each other such that nosecone 214 and capsule 206 are in contact with each other, and delivery assembly 200 can be withdrawn from lumen 114 of crimping device 100 .

The delivery assembly 200 can then be inserted into the patient's vasculature, and the delivery device 204 can be used to deliver the prosthetic heart valve 202 to the desired implantation site (eg, the native aortic annulus).

13-14 show a crimping device 300 according to another embodiment. Broadly speaking, crimping device 300 includes housing 302 and crimping band 304 and adjustable loop 306 that function similarly to housing 102, crimping band 104, and loop 108 of crimping device 100, respectively, in that: Crimping device 300 is similar to crimping device 100 . Crimping device 300 differs from crimping device 100 in several respects. For example, the crimping band 304 of the crimping apparatus 300 is configured such that the ends 308 of the crimping band 304 can move relative to the housing 302, while the crimping band 104 is Only second end 126 is configured to be movable relative to housing 102 (eg, during normal operation). Crimp band 304 also includes a plurality of stop elements 310 disposed along its length, while crimp band 104 has a substantially uniform diameter along its length. 15-17, crimping device 300 includes a locking mechanism integrally formed with housing 302, while crimping device 100 has a separate locking mechanism 106 coupled to housing 102. . Additional details regarding crimping apparatus 300 and its components are provided below.

13-14, the housing 302 of the crimping device 300 includes a base 312 and a body 314. As shown in FIG. Body 314 includes a lumen 316 configured to allow insertion of a delivery assembly (see, eg, FIGS. 6-7). Body 314 also includes a band aperture 318 extending from an inner surface 320 of body 314 (which defines lumen 316 ) to an outer surface 322 of body 314 . The band openings 318 are circumferentially spaced from one another and can be configured to receive the crimping band 304 .

It should be noted that loop 306 of crimping band 304 is shown as having a circular shape for purposes of illustration. However, if the prosthetic heart valve is not placed within the loop 306 and the crimping band 304 is pulled, the loop 306 will disappear (or be tied) and the crimping band 304 will be substantially flat. deaf.

Turning now to FIG. 15, each band aperture 318 can include an actuating portion 324, a locking portion 326, and a connecting portion 328 disposed between the actuating portion 324 and the locking portion 326. As shown in FIG. Actuating portion 324 can be larger (eg, radially) than locking portion 326 and connecting portion 328 . In some embodiments, locking portion 326 can be larger than connecting portion 328 . In other embodiments, locking portion 326 and connecting portion 328 can be the same size.

As shown in FIG. 16, the actuation portion 324 of the band opening 318 can be configured to allow the stop element 310 of the crimping band 304 to pass therethrough. Thus, when the crimping band 304 is moved relative to the housing 302 , the crimping band 304 can align with the actuation portion 324 of the band opening 318 .

As shown in FIG. 17, locking portion 326 and connecting portion 328 of band opening 318 are configured to allow the main portion of crimping band 304 (i.e., the portion between stop elements 310) to pass through and to allow the crimping band to pass through. It can be configured such that the stop element 310 of 304 cannot pass. Therefore, adjusting the crimping band 304 to the desired diameter relative to the housing 302 by moving the crimping band 304 through the working portion 324 of the band opening 318 results in the movement from the working portion 324 of the band opening 318 to the connecting portion 328 of the band opening 318 . The crimping band 304 can be moved into the locking portion 326 of the band opening 318 through the. In this "locked" configuration, stop element 310 of crimping band 304 engages outer surface 322 of housing 302 adjacent band opening 318, thereby limiting relative movement between crimping band 304 and housing 302. can do.

In some embodiments, the stopper elements can be evenly spaced with respect to each other. In other embodiments, the stop elements can be unevenly spaced. For example, stop elements positioned toward the ends of the crimping band can be spaced further apart from adjacent stop elements than stop elements positioned in the central portion of the crimping band.

A stop element 310 of the crimping band 304 can extend radially outwardly from the main portion of the crimping band 304 . For example, in the illustrated embodiment, the stop element 310 has a frusto-conical shape extending radially outward from the crimping band 304 . In some embodiments, as shown, the smaller radial portion of each stop element can be positioned closer to the adjacent end than the larger radial portion. This configuration allows the crimping band 304 to move in one direction relatively easily than the other. Specifically, due to this "directional" configuration, the crimping band 304 moves from the inner surface 320 to the outer surface 322 of the housing 302 more than when moving from the outer surface 322 to the inner surface 320 of the housing 302. It can easily pass through the opening 318 . In some cases, when the crimping band 304 is aligned with the actuating portion 324 of the band opening 318 (eg, when the crimping band is being pulled), the end 308 of the crimping band 304 is pulled out of the housing 302. End 308 is positioned in housing 302 so that it can be moved apart and when crimping band 304 is aligned with locking portion 326 of band opening 318 (e.g., when the crimping band is loosened). The stop element 310 can be configured so that it cannot move toward the . In other words, the diameter of the loop 306 of the crimping band 304 can be decreased, but it cannot be expanded when the stopper element 310 is aligned with the locking portion 326 of the band aperture 318 .

In other embodiments, the stopper element can include various other shapes. For example, the stop element may comprise an outwardly projecting tab or leg, such as a T-shape or V-shape in a plane parallel to the longitudinal axis of the crimping band. In some such embodiments, the band opening can include a rectangular cross-sectional profile such that the stop element of the crimping band aligns the tab with the long axis of the rectangular opening in a first orientation. When oriented (e.g., vertically), the crimping band stop element is allowed to pass through the band opening, and the crimping band stop element squares the tab so that the tab contacts the outer surface of the housing. When in a second orientation (eg, horizontal) aligned with the minor axis, it limits movement of the stopper element of the crimping band relative to the housing. Thus, the crimping band can be moved between locked and unlocked states by rotating (eg, twisting) the crimping band (eg, 90 degrees) relative to the housing.

Crimping apparatus 300 can be used to crimp a mechanically expandable heart valve prosthesis (eg, heart valve prosthesis 202). When the loops 306 of the crimping band 304 are in the radially expanded configuration (eg, FIG. 13), insert the radially expanded prosthetic heart valve and the end of the delivery device into the lumen 316 of the housing 302. can do. The end 308 of the crimping band 304 is then aligned with the actuation portion 324 of the band opening 318 of the housing 302 (see, eg, FIG. 16) to move the end 308 of the crimping band 304 away from the housing 302. can reduce the diameter of the loops 306 of the crimping band 304 by . As a result, the crimping band loops 306 contact the prosthetic heart valve and exert a radially inward force on the prosthetic heart valve.

By moving the crimping band 304 relative to the housing 302 from the actuating portion 324 of the band opening 318, through the connecting portion 328 of the band opening 318, and into the locking portion 326 of the band opening 318, as shown in FIG. The valve can be held in radial compression. Accordingly, stop element 310 of crimping band 304 contacts outer surface 322 of housing 302 , thereby limiting relative movement (eg, at least slack) between crimping band 304 and housing 302 .

The prosthetic heart valve can be partially loaded into the capsule of the delivery device. The capsule of the delivery device can hold the heart valve prosthesis in a radially compressed configuration, and the crimping device 300 can be released from the heart valve prosthesis. To release the heart valve prosthesis, the crimping band 304 can be moved relative to the housing 302 so that the stopper element 310 radially aligns with the working portion 324 of the band aperture 318 . The crimping band 304 can be loosened such that the diameter of the loops 306 of the crimping band 304 increases. The heart valve prosthesis and delivery device can be retracted from within the loop 306 and the capsule of the delivery device can be advanced over the rest of the heart valve prosthesis, or vice versa.

The crimping devices described herein are quick, easy to use, and inexpensive to manufacture compared to typical crimping devices, which often have complex mechanisms.

Although the disclosed crimping device is primarily described for use with prosthetic heart valves, it should be noted that the disclosed crimping device can also be used with other implantable devices (eg, stents). .

Features described herein in relation to any example may be combined with other features described in any one or more of the other examples, unless stated otherwise. For example, one or more features of the crimping device 100 can be combined with one or more features of the crimping device 300. In particular, crimping band 304 can be used in crimping apparatus 100 in place of crimping band 104 .

Considering the many possible embodiments in which the principles of the present disclosure can be applied, it is recognized that the illustrated embodiments are merely preferred examples and should not be construed as limiting the scope of the claims. should. Rather, the scope of claimed subject matter is defined by the following claims and their equivalents.

100 crimping device
102 housing
104 crimping band
106 locking mechanism
108 loops
110 base
112 Body
114 Lumen
116 First opening
118 Second opening
120 exterior
122 Inside
124 first end
126 second end
128 stopper element
130 Jaw
132 mating feature
134 Arrows
136 indicators
138 Spring load cell
200 delivery assembly
202 Artificial Heart Valve
204 delivery device
206 capsules
208 frames
210 outer shaft
212 inner shaft
214 Nosecone
300 crimping device
302 Housing
304 crimping band
306 loops
308 end
310 stopper element
312 base
314 body
316 Lumen
318 band opening
320 inside
322 External
324 Actuating Parts
326 lock part
328 connection part

Claims (46)

a housing having a lumen configured to receive a prosthetic heart valve;
a crimping band adjustably coupled to the housing and including a first end, a second end and a loop;
A crimping device comprising:
the loop of the crimping band is disposed within the lumen of the housing and is movable between a first configuration and a second configuration;
In the first configuration, the loop of the crimping band has a first diameter and is capable of radially disposing the heart valve prosthesis in a radially expanded configuration within the loop. is configured as
In the second configuration, the loop of the crimping band has a second diameter and exerts a radial force on the prosthetic heart valve to radially expand the prosthetic heart valve. configured to move from a configuration to a radially compressed configuration;
The crimping device, wherein the loop of the crimping band is configured to contact less than half the axial length of the prosthetic heart valve. 2. The crimping device of claim 1, wherein the loop of the crimping band is configured to contact less than one quarter of the axial length of the prosthetic heart valve. 2. The crimping device of claim 1, wherein the loop of the crimping band is configured to contact less than one-eighth of the axial length of the prosthetic heart valve. The first end of the crimping band is fixed relative to the housing and the second end of the crimping band connects the loops of the crimping band to the first configuration and the second configuration. 4. A crimping device according to any one of claims 1 to 3, wherein the crimping device is movable relative to the housing so as to move between a configuration of . The first and second ends of the crimping band are movable relative to the housing to move the loops of the crimping band between the first configuration and the second configuration. 4. A crimping device according to any one of claims 1 to 3, wherein The housing includes a band opening extending from the lumen of the housing to an outer surface of the housing, the band opening configured to allow the crimping band to extend through the band opening. 6. A crimping device according to any one of claims 1 to 5, wherein the crimping device comprises: The band opening in the housing includes an actuating portion and a locking portion, and the crimping band moves relative to the housing when the crimping band is radially aligned with the actuating portion of the band opening. 7. The housing limits relative movement between the crimping band and the housing when the crimping band is radially aligned with the locking portion of the band opening. The crimping device according to . 8. The crimping device of any one of claims 1-7, further comprising a locking mechanism coupled to the housing and configured to limit relative movement between the crimping band and the housing. 9. The crimping device of claim 8, wherein the locking mechanism is positioned adjacent the band opening in the housing. 10. The locking mechanism of claim 8 or 9, wherein the locking mechanism includes a plurality of jaws, the jaws being movable between an open configuration spaced from the crimping band and a closed configuration contacting the crimping band. A crimping device as described. 11. The crimping apparatus of Claim 10, wherein the jaws include mating features configured to retain the jaws in the closed configuration. 12. The crimping apparatus of claim 11, wherein the mating features of the jaws include interlocking tabs extending from the jaws. 13. The crimping device of any one of claims 1-12, wherein the crimping band includes an indicator configured to indicate to a user that the prosthetic heart valve is fully radially compressed. The claim further comprising one or more stop elements extending outwardly from said crimping band, said stop elements configured to limit relative movement between said crimping band and said housing. 14. A crimping device according to any one of clauses 1-13. 15. A crimping device according to any preceding claim, wherein the crimping band has only one loop. A crimping device for a mechanically expandable heart valve prosthesis, comprising:
A housing including a base and a body, the body extending from the base and including a lumen configured to receive a mechanically expandable heart valve prosthesis, the body having a first opening and a second opening. a housing further comprising an opening, wherein said first opening and said second opening are spaced apart and extend from an inner surface of said body defining said lumen to an outer surface of said body;
A crimping band comprising a first end, a second end and only one loop disposed between said first and second ends, said loop of said crimping band comprising: a crimping band comprising a width less than the axial length of the mechanically expandable heart valve prosthesis;
A crimping device, comprising: 17. The crimping device of claim 16, wherein said crimping band is a flexible polymer band. 17. The crimping device of Claim 16, wherein the crimping band is a flexible suture. 17. The crimping device of Claim 16, wherein the crimping band is a flexible wire. A method of crimping an implantable device, comprising:
placing the implantable device within a loop of a crimping band, the implantable device being in a radially expanded state;
pulling the crimping band so that the diameter of the loop decreases and contacts a first portion of the implantable device and moves the implantable device to a radially compressed configuration; The crimping band is configured to exert a radial compressive force on the implantable device when the crimping band is tensioned, and the first portion of the implantable device is axially aligned with the implantable device. a step comprising less than half of the directional length;
A method, including Further comprising advancing the capsule of the delivery device over a second portion of the implantable device while the crimping band is tensioned, the second portion being half the axial length of the implantable device. 21. The method of claim 20, comprising less than. further comprising loosening the crimping band and advancing the capsule of the delivery device across the first portion of the implantable device and the third portion of the implantable device; 22. The method of claim 21, wherein the portion, the second portion, and the third portion together comprise the axial length of the implantable device. a housing having a lumen and one or more band openings, the lumen configured to receive a prosthetic heart valve therein;
a crimping band adjustably coupled to the housing and including a first end, a second end and a loop;
A crimping device comprising:
The first end is coupled to the housing, the second end extends through the one or more band openings, and the loops of the crimping band extend within the lumen of the housing. arranged in and movable between a first configuration and a second configuration,
In the first configuration, the loop of the crimping band has a first diameter such that the prosthetic heart valve in a radially expanded configuration can be radially positioned within the loop. is configured to
In the second configuration, the loop of the crimping band has a second diameter and exerts a radial force on the prosthetic heart valve to cause the prosthetic heart valve to expand in the radially expanded configuration. to a radially compressed configuration. 24. The crimping device of claim 23, wherein the first end of the crimping band is fixedly attached to the housing. 24. The crimping device of Claim 23, wherein the first end of the crimping band is movably coupled to the housing. 26. The crimping device of any one of claims 23-25, wherein the one or more band openings is a plurality of band openings. The plurality of band openings includes a first band opening and a second band opening, the first end of the crimping band extending through the first band opening, and the crimping band 27. The crimping device of Claim 26, wherein the second end extends through the second band aperture. 28. A crimping device according to any one of claims 23-27, wherein at least one of said one or more band openings comprises an actuating portion and a locking portion. 29. The crimping device of claim 28, wherein said at least one of said one or more band apertures is larger in said actuation portion than in said locking portion. 30. A crimping device according to claim 28 or 29, wherein said at least one of said one or more band apertures includes a connecting portion disposed between said actuating portion and said locking portion. 31. The crimping device of any one of claims 23-30, wherein the loop of the crimping band is configured to contact less than a quarter of the axial length of the prosthetic heart valve. 32. The crimping device of any one of claims 23-31, wherein the loop of the crimping band is configured to contact less than one eighth of the axial length of the prosthetic heart valve. 33. A crimping device according to any one of claims 23-32, wherein the crimping band comprises one or more stop elements. 34. The crimping device of claim 33, wherein the one or more stop elements are a plurality of stop elements axially spaced from one another. 35. The crimping device of any one of claims 23-34, further comprising a locking mechanism coupled to the housing and configured to limit relative movement between the crimping band and the housing. 36. The crimping device of claim 35, wherein the locking mechanism is positioned adjacent the one or more band openings. 37. The locking mechanism of claim 35 or 36, wherein the locking mechanism includes a plurality of jaws, the jaws being movable between an open configuration spaced from the crimping band and a closed configuration contacting the crimping band. A crimping device as described. 38. The crimping apparatus of claim 37, wherein the jaws include mating features configured to retain the jaws in the closed configuration. 39. The crimping apparatus of claim 38, wherein the mating features of the jaws include interlocking tabs extending from the jaws. 40. The crimping device of any one of claims 23-39, wherein the crimping band includes an indicator configured to indicate to a user that the prosthetic heart valve is fully radially compressed. 41. A crimping device according to any one of claims 23-40, wherein the crimping band has only one loop. 42. The crimping device of any one of claims 1-19 or 23-41, further comprising a force control mechanism configured to limit and/or indicate the force applied to the crimping band. 43. The crimping device of claim 42, wherein the force control mechanism includes a spring load gauge. 43. The crimping device of claim 42, wherein the force control mechanism includes a portion of the crimping band that elongates when the force applied to the crimping band reaches a predetermined amount. a mechanically expandable prosthetic heart valve;
a crimping device according to any one of claims 1-19 or 23-44;
Assembly containing . 46. The assembly of Claim 45, further comprising a delivery device.

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